Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series (original) (raw)
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Catheterization and Cardiovascular Interventions, 2016
Background: The Occlutech Figulla ASD device series (OFSO) shows an improved device design for interventional ASD closure, larger follow-up series are missing. Methods: We retrospectively reviewed the feasibility, safety, implantation properties, results, and follow-up of ASD closure using Occlutech devices over a 5 year period by establishing a multi-institutional collaborative result registry with 16 contributing
Journal of interventional cardiology, 2016
To evaluate the mid-term outcomes after percutaneous closure of the secundum atrial septal defects (ASD) using the Figulla-Occlutech device (FOD). Transcatheter closure has become the method of choice for most patients with ASD. Although the FOD may have some advantageous characteristics there is a paucity of data on later outcomes after the use of this relatively new device. Observational, single arm study including 200 non-consecutive patients who underwent ASD closure between 04/09 and 07/15 in 2 centers. Device performance, deployment technique, and immediate and mid-term outcomes were assessed. Median age and weight were 24 years (4-72) and 58 kg (15-92), respectively. Single defects were observed in 171 patients (median size of 19 mm). The remainder had multiple or multifenestrated defects. Implantation of FOD (median size of 24 mm) was successful in all (99%), but 2 patients (1 with deficient postero-inferior rim; 1 with a large ASD for the size of the child). Embolization wi...
Türk Kardiyoloji Derneği arşivi : Türk Kardiyoloji Derneğinin yayın organıdır, 2010
We evaluated the efficiency and safety of the Occlutech Figulla device in percutaneous closure of secundum atrial septal defects (ASD). The study included 28 patients (17 women, 11 men; mean age 43 years) who underwent percutaneous transcatheter closure using the Occlutech Figulla device for secundum ASDs causing a hemodynamically significant shunt. Defect size was estimated by transthoracic (TTE) and transesophageal (TEE) echocardiography, and also by balloon sizing in nine patients. The patients were followed-up for six months and were examined by TTE. The mean defect size was 20.3+/-2.1 mm on TTE, 22.1+/-1.9 mm on TEE, and 24.2+/-2.4 mm on balloon sizing. The mean device size was 26.8+/-3.6 mm (range 6 to 36 mm). The mean procedure time was 44.7+/-21.4 minutes. The device was placed successfully in all the patients. A small residual flow was seen immediately after device placement in three patients (10.7%), which disappeared in two patients at three months, and in one patient at ...
2012
Objective: To evaluate the effectiveness of the Occlutech Figulla occluder device in the treatment of ostium secundum atrial septal defect. Methods: This is a retrospective review which was conducted between June 2008-June 2011 involving 54 cases with ostium secundum atrial septal defect who underwent transcatheter closure using the Occlutech Figulla device at Queen Alia Heart Institute. All procedures were performed under general anaesthesia with continuous Transesophageal Echocardiographic monitoring. Clinical and echocardiographic assessments were performed after 24 hours and then after one, three and six months respectively. The results are presented as means, standard deviations and percentages. Results: From the 54 cases, 33 patients (61%) were females. Their mean age and weight were 16.47±11.8 year, 38.4 ± 20.7kg respectively. The mean atrial septal defect diameter by Transesophageal Echocardiogram was 13.2 ± 4.2mm, and the mean atrial septal defect size of the implanted devi...
Catheterization and Cardiovascular Interventions, 2014
Objectives: To evaluate the feasibility, safety, and efficacy of implantation of the new Nit Occlud ASD-RV R (NOASD-R) device for percutaneous closure of ostium secundum atrial septal defects (ASD-OS). Background: Device catheter implantation has become the method of choice for most patients with ASD-OS. No single device has proven to be ideal for this type of procedure. The NOASD-R has a distinct design that may help to overcome limitations of other devices. Methods: A prospective, single arm, observational study including all consecutive patients receiving the NOASD-R device for ASD-OS closure between October 2011 and September 2013 was performed. Patient selection, device design, deployment technique, complications, and procedural outcomes were evaluated. Results: Seventy-four patients underwent attempted transcatheter ASD-OS closure using the NOASD-R device. Implantation of the occluder was successful in 73 patients (98.6%). The majority of patients were female (79.5%) with a median age of 17.2 years (range: 2-74). A 2-D transthoracic color-Doppler echocardiogram (TTE) obtained at the 3 or 6 month follow-up visit showed complete occlusion of the ASD-OS in 72/73 patients (98.6%). At a mean follow-up interval of 11.4 6 6.8 months there have been no episodes of late device embolization, cardiac perforation or erosion, endocarditis, thromboembolism, wire fracture, embolic neurologic events, or death. Conclusions: We report the first worldwide clinical experience using the NOASD-R device for ASD-OS closure. The procedure was feasible, with a high rate of successful implantations, and safe. High ASD-OS closure rates and no complications were encountered during short-term follow-up. V C 2014 Wiley Periodicals, Inc.
Journal of interventional cardiology, 2012
Background: Percutaneous closure of secundum type atrial septal defect (ASD) and patent foramen ovale (PFO) has gained widespread use in recent years. Herein, we evaluated the safety and efficacy of the Occlutech R Figulla devices for PFO and ASD closure in a reference tertiary center. Methods: All 143 patients (46.9% male, mean age 39.3 ± 12.2 years) who underwent transcatheter PFO (n = 85) and ASD (n = 58) closure with Occlutech R Figulla devices between February 2009 and October 2011 were included in this study. An echocardiographic follow-up examination was performed at the 1st, 6th, and 12th month visits. Results: The devices were successfully implanted in all 143 patients (100%). In-hospital periprocedural complications were device embolization (0.7%; 1 ASD patient), atrial fibrillation (1.4%; 1 ASD and 1 PFO patients), supraventricular tachycardia (0.7%; 1 PFO patient), and vascular access hematoma (0.7%; 1 ASD patient). Among ASD patients, 2 patients had trivial (jet width <1 mm in diameter) and 1 patient had small (1-2 mm) residual shunts before hospital discharge, which disappeared after the 6-month visit. During the mean 15.4 ± 9.6 months follow-up, all patients were asymptomatic and no ischemic stroke, cardiac perforation, device erosion, embolization, thrombus formation, or malposition of the device was observed. Conclusions: Percutaneous PFO and secundum type ASD closure with the novel Occlutech R Figulla Occluder devices without left atrial central pin and with significantly reduced meshwork was safe, feasible, and effective. (J Interven Cardiol 2012; * * :1-7)
Cardiovascular Diagnosis and Therapy
Background: The last decades have brought remarkable improvements in treatment strategy and occluder modification of secundum atrial septal defect (ASD) closure. Approval, efficacy and safety of ASD closure devices have previously been demonstrated. This study investigated the clinical efficacy and safety of the LifeTech CeraFlex TM ASD occluder for interventional closure of secundum ASD with a 6-month follow-up (FU). Methods: Procedure specific data was collected on patients considered for ASD closure with the CeraFlex TM occluder between April 2016 and December 2019 in three German centers. Efficacy and safety were assessed after device closure, at discharge, and at 6-month FU. Results: The primary endpoint (successful ASD closure without severe complications) was reached by 102/103 patients (99%). Device embolization occurred in two patients (one early and one late embolization). After early snare-retrieval of an embolized device, this ASD was closed surgically and in the other patient with late device embolization the defect was closed with a larger CeraFlex TM occluder. The secondary endpoint (clincal efficacy after 6 months) was reached by 94/98 patients since new onset of arrhythmia occurred in four patients. Three patients had withdrawn their study-participation and one patient had moderate residual shunt, but not related to the occluder. Incomplete right bundle branch block (iRBBB) was seen in 31 patients. At last FU only 17 patients had remaining iRBBB documenting effective volume unloading of the right ventricle. Conclusions: Catheter interventional closure of secundum ASDs with the CeraFlex TM ASD occluder was feasible, safe and effective in this study.
Journal of Interventional Cardiology, 2022
Objectives To assess the long-term safety and efficacy of the Occlutech® ACCELL® Flex II device used for atrial septal defect (ASD) closure. This device differs from the regular device by having two very thin patches that are made of polyethylene terephthalate (PET). These patches enhance faster sealing of the defect. Background Transcatheter closure has become the method of choice to manage most patients with secundum ASDs. There are different types of devices. The regular Occlutech device used to close an ASD is called the Occlutech Figulla Flex II. A newer modification of this device (Occlutech® ACCELL® Flex II) has been designed to eliminate/reduce thrombus formation and to enhance faster sealing. Methods Thirty patients were followed up after occlusion of secundum ASD using the Occlutech® ACCELL® Flex II Device. The follow-up period ranged from 5.2–5.5 years with median of 5.3 years. Detailed history and full clinical examination, twelve-lead electrocardiogram (ECG), plain ches...
Journal of the Saudi Heart Association, 2017
Background: Closure of atrial septal defect (ASD) among adults under transthoracic echocardiography (TTE) guidance using devices other than the Amplatzer Septal Occluder has not been extensively tested. Aim of work: Assessment of the safety and efficiency of secundum ASD closure using the Occlutech Figulla ASD Occluder under TTE guidance in adult patients with hemodynamically significant secundum ASD. Methods: Twenty patients (mean age, 32.9 þ 9.7, 75% of them females) were enrolled in the study. All patients underwent TTE and transoesophageal echocardiography (TEE) to assess the characteristics of the ASD prior to percutaneous closure. Procedures were performed using the Figulla Occluder device under both fluoroscopic and TTE guidance. Follow-up clinical and TTE examinations were done at 1, 3, and 6 months following the procedure. Results: TTE estimated mean ASD size was 21.7 þ 7.3 mm with adequate rims except for the aortic rim (deficient in one third of cases). Mean device size was 28.1 þ 8.6 mm with mean procedure and fluoroscopic times of 46.2 þ 16.4 and 15.7 þ 5.4 minutes respectively. ASD was successfully closed in all patients. Two patients showed a small residual shunt immediately after the device placement that disappeared by the end of the 2nd followup TTE examination. Transient complications were detected in 2 patients. All patients were asymptomatic during the follow-up period. Conclusion: Transcatheter closure of secundum ASD in adults under TTE guidance using the Occlutech Figulla ASD occluder device is safe and effective when performed in a tertiary center and by expert echocardiographers and interventional cardiologists.